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Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 Definition of a drug includes articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals FDA has asserted jurisdiction in cases where the manufacturer or vendor has made medical claims FDA has asserted jurisdiction over alternative nicotine-delivery products 1984Nicotine Polacrilex gum 1991Nicotine patches Federal Trade Commission (FTC) Act of 1914 (amended in 1938) Empowers the FTC to prevent persons, partnerships, or corporations from using unfair or deceptive acts or practices in commerce 1983FTC determines that its testing procedures may have significantly underestimated the level of tar, nicotine, and carbon monoxide that smokers received from smoking certain low-tar cigarettes

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How Tobacco Smoke Causes Disease: The Biology and Behavioural Basis for Smoking-Attributable Disease